Journal of Jishou University(Natural Sciences Edition)

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Performance Verification and Analysis of Electrophoretic Fluorimeter Based on AFP, AFP-L3 and PIVKA-Ⅱ

XING Yan, FENG Changhuan, DU Lijun   

  1. (1. School of Mathematics and Information, China West Normal University, Nanchong 637000, Sichuan China; 2. Department of Medical Laboratory, Nanchong Central Hospital, Nanchong 637000,  Sichuan China)
  • Online:2019-07-25 Published:2019-07-31


Outpatients in a 3A (Grade A) Hospital in Nanchong City have been randomly selected. According to the EP-6A2 document announced by CLSI, the precision, linear range and accuracy of μTASWakoi30 have been verified by combining alpha-fetoprotein (AFP) and its heterogeneity ratio (AFP-L3) with abnormal prothrombin (PIVKA-Ⅱ) reagent specification. The results showed that the precision CV of μTASWakoi30 was below 10%, and the precision of AFP and PIVKA-Ⅱ were all below 10%, and AFP and PIVKA-Ⅱ were fitted well by the regression of mean value and predicted value in different proportion of high value samples. The recoveries were within 80%~120% at different calibration levels and the accuracy was high.

Key words: electrophoretic fluorescence immune-analyzer, AFP, PIVKA-Ⅱ, performance verification

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